When news broke this month that Johnson & Johnson sold transvaginal mesh without the Food & Drug Administration’s approval, it was the latest blow for the consumer-products conglomerate, which is also dealing with thousands of defective hip claims involving its DePuy hip implant.
In fact, Johnson & Johnson had received explicit instructions in August 2007 to stop marketing and selling transvaginal mesh under its Gynecare Prolift line. The government’s federal watchdog requested information on 16 potential deficiencies in the product.
Defective medical product attorneys have begun to litigate thousands of cases involving faulty transvaginal mesh or defective hip replacements manufactured by Johnson & Johnson.
Transvaginal Mesh Litigation:
-Johnson & Johnson began selling the Gynecare Prolift product in 2005, without applying for a new application for the FDA, saying it was substantially similar to other products that had won FDA approval. Extended negotiation resulted in the FDA approving the product in 2008.
-From 2005 to 2010, nearly 4,000 cases of injury or death resulted from the use of transvaginal mesh (TVM) implants used to treat pelvic organ prolapse (POP). Surgical mesh has been around since the 1950s and was initially used to repair abdominal hernias. In the 1970s, it began to be used for POP repair and in the 1990s, surgeons began using it to treat stress urinary incontinence.
-Side effects and medical complications associated with transvaginal mesh can include infection, urinary problems, bowel perforation, organ damage and pelvic pain.
DePuy Hip Recall
-In 2010, Johnson & Johnson recalled its ASR XL hip-replacement system. The system became available in the United States in 2005 — after J&J received special clearance from the FDA to market the devices without first performing clinical trials to determine the safety of the hip-replacement system.
-The company has since acknowledged high failure rates, saying 12 percent of patients needed “revision surgery.” Defective product attorneys believe the actual proportion of patients needing additional surgery will be much higher over the life of the product. DePuy, a division of Johnson & Johnson, reported dislocations, infections, bone fractures, metal sensitivity and pain are all common side effects of the defective hip. Swelling, nerve damage, tissue damage, and muscle damage may also result.
Worldwide, some 93,000 patients had the defective hip-replacement system implanted in their bodies. With the metal-on-metal system, both the ball and socket are made of metal, which the company promoted as stronger and more reliable. However, victims of defective hips have been forced to contend with metal shavings in tissue around the implants.
While many consumers want to believe medical devices are rigorously tested by the government to ensure safety and the highest quality-control standards, veteran medical malpractice attorneys understand that is simply not the case.
Safety advocates continue to call for reforms. Among the most egregious issues endangering patient safety are:
-The FDA too often permits device makers to bring products to market without proper testing by expediting the approval process for devices the manufacturer contends are “substantially similar” to existing products already approved.
-Device and drug markers are permitted to conduct clinical trials in Third World countries, far from the prying eyes or regulators.
-The government often conducts no independent study regarding a product’s safety, instead relying upon the studies conducted by the device manufacturer.